Transcatheter Mitral Valve Replacement: Long-Term Outcomes of First-in-man Experience with an Apically Tethered Device- a Case Series from a Single Centre.

Aims: Transcatheter mitral valve replacement (TMVR) is a novel technique for treating mitral regurgitation. We report 18-month/two-year outcomes of the five first-in-man patients undergoing chronic TMVR with the Tendvne device.Methods and results: Five patients (STS score range 14%-23%) underwent TMVR using the Tendvne system under compassionate use at a single centre. One patient (who was non-compliant with anticoagulation) died nine months after TMVR following a cerebrovascular accident. Whilst sonic of the remaining patients experienced recognised post-TMVR complications (left ventricular outflow tract obstruction, para-valvular leak, stent thrombosis), all patients alive at 18 mouths/two years after TMVR reported significant reduction in NYIIA class and increase in exercise capacity compared to baseline. Transthoracic echocardiography demonstrated valve stability, absent transvalvular mitral regurgitation, and significant reductions in tricuspid regurgitation severity and systolic pulmonary arterial pressure.Conclusions: Eighteen months/two years after compassionate use of the Tendvne system in a high-risk surgical group, the majority of patients were alive, patient symptoms improved, and the device was stable with good haemodynamic function, no late migration and no new paravalvular leak. Continued follow-up of patients treated with the Tendvne system is required in order to describe its safety and efficacy further.